RXi Pharmaceuticals announces completion of dosing in Phase 1 RXI-109 trial

theflyonthewall.com

RXi Pharmaceuticals announced that dosing with their first drug in its first Phase 1 study, was completed last week. RXI-109 is being developed to prevent or reduce dermal scarring following surgery or trauma, as well as for the management of hypertrophic scars and keloids. Over the past 3 months, 15 subjects who are scheduled to undergo abdominoplasty in the coming months, were enrolled in a double-blind dose, escalation study during which single intradermal injections were administered in a dose dependent manner to 5 cohorts of 3 subjects each. Subjects received an injection of RXI-109 in 2 separate areas on the abdomen and placebo injections in two other areas of the abdomen. Data on safety and tolerance were collected and evaluated for each cohort before moving to the next cohort with a higher dose level. RXI-109 was well tolerated by intradermal injection. No serious local or systemic side effects were observed in the subjects at any of the doses administered. Local erythema around the injection site was somewhat more pronounced in the cohort that received the highest dose, but these instances of redness disappeared usually within 72 hours after the injection, and did not give rise to significant subjective complaints from the study subjects.

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